NCT06793072

Brief Summary

The aim of the study is to compare the concentrations of leptin, resistin, and omentin-1 in women across three research groups: those with polycystic ovary syndrome without insulin resistance, those with polycystic ovary syndrome with insulin resistance, and women without polycystic ovary syndrome.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

January 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

January 20, 2025

Last Update Submit

March 17, 2026

Conditions

Keywords

insulin resistancepolycystic ovary syndromemetabolic syndromeadipokines

Outcome Measures

Primary Outcomes (3)

  • Comparison of resistin concentration in three study groups

    Measurement and comparison of mean fasting plasma resistin concentration expressed in pg/ml in three study groups

    up to 6 months

  • Comparison of leptin concentration three study groups

    Measurement and comparison of mean fasting plasma leptin concentration expressed in pg/ml in three study groups

    up to 6 months

  • Comparison of omentin-1 concentration in three study groups

    Measurement and comparison of mean fasting plasma omentin-1 concentration expressed in pg/ml in three study groups

    up to 6 months

Study Arms (3)

PCOS+IR

Polycystic ovary syndrome + insulin resistance

Diagnostic Test: Leptin concentration in blood serumDiagnostic Test: Resistin concentration in blood serumDiagnostic Test: Omentin-1 concentration in blood serum

PCOS + no IR

Polycystic ovary syndrome + no insulin resistance

Diagnostic Test: Leptin concentration in blood serumDiagnostic Test: Resistin concentration in blood serumDiagnostic Test: Omentin-1 concentration in blood serum

No PCOS

Women without PCOS (control)

Diagnostic Test: Leptin concentration in blood serumDiagnostic Test: Resistin concentration in blood serumDiagnostic Test: Omentin-1 concentration in blood serum

Interventions

Fasting plasma leptin concentration measurement with results expressed in pg/ml and comparison across all study arms

No PCOSPCOS + no IRPCOS+IR

Fasting plasma resistin concentration measurement with results expressed in pg/ml and comparison across all study arms

No PCOSPCOS + no IRPCOS+IR

Fasting plasma omentin-1 concentration measurement with results expressed in pg/ml and comparison across all study arms

No PCOSPCOS + no IRPCOS+IR

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

women aged 18-45 years managed for menstrual irregularities or routine check-up

You may qualify if:

  • Age 18-45

You may not qualify if:

  • previous removal of at least one ovary
  • treated diabetes of any type
  • diagnosed and treated metabolic diseases
  • diagnosed and treated autoimmune diseases
  • diagnosed and treated autoinflammatory diseases(Edited)Restore original

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian Univeristy

Krakow, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood serum

MeSH Terms

Conditions

Insulin ResistancePolycystic Ovary SyndromeMetabolic Syndrome

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Kazimierz Pityński, Prof., Ph.D., M.D.

    Jagiellonian University

    STUDY CHAIR

Central Study Contacts

Iwona Gawron, Ph.D., M.D.

CONTACT

Robert Jach, Prof., Ph.D., M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD, Principal Investigator

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

January 20, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations